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Completed

NCT Number: NCT03101878

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers

The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IONIS AGT-LRx in up to 82 Healthy Volunteers

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Key information

Conditions

Healthy Volunteers

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Syneos Health

Toronto, Ontario, M5V 2T3, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have given written informed consent and be able to comply with all study requirements
  • Healthy males or females aged 18-60 inclusive and weighing ≥ 50 kg at the time of Informed Consent
  • Females must be non-pregnant and non-lactating, and either surgically sterile or post- menopausal
  • Males must be surgically sterile, abstinent or using an acceptable contraceptive method
  • BMI ≤ 35 kg/m
  • Agree to conduct at home blood pressure monitoring (in triplicate using study provided device) every morning and every evening throughout study participation for Single-Dose Cohort subjects and every morning for Multiple-Dose Cohort subjects

Exclusion criteria

  • Treatment with another Study Drug, biological agent, or device within one-month of Screening
  • Subject with borderline orthostatic hypotension defined as a fall in systolic blood pressure of ≥ 17 mmHg or diastolic blood pressure of ≥ 7 mmHg when they assume a standing position (within 3 minutes of standing up)
  • Use of nicotine-containing products or illicit drugs
  • Considered unsuitable for inclusion by the Principal Investigator

Treatment and study plan

Ionis AGT-LRx

Drug

Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously

Placebo

Drug

Saline .9%

Primary outcomes

  1. Incidence and severity of adverse events that are related to treatment with IONIS AGT-LRx

    Time frame: Up to 127 days

    The safety and tolerability of single and multiple doses of IONIS AGT-LRx will be assessed by determining the incidence, severity, and dose relationship of adverse events that are related to treatment with IONIS AGT-LRx

  2. Any observed changes in Blood Pressure measurements, ECGs, or laboratory tests from baseline

    Time frame: Up to 127 days

    The safety and tolerability of single and multiple doses of IONIS AGT-LRx will be assessed by reviewing any observed changes in Blood Pressure measurements, physical exam, and laboratory tests from baseline by dose. Results in subjects dosed with IONIS AGT-LRx will be compared with those from subjects dosed with placebo.

Secondary outcomes

  1. Pharmacokinetics after single and multiple doses of IONIS AGT-LRx

    Time frame: Up to 127 days

    The plasma pharmacokinetics (concentration-time results) of IONIS AGT-LRx will be assessed following single and multiple dose SC administration

  2. Pharmacodynamics of IONIS AGT-LRx (Changes in plasma AGT Levels)

    Time frame: Up to 127 days

    Effects of IONIS AGT-LRx on changes in AGT plasma protein compared to baseline.

Sponsors and collaborators

Lead sponsor

Ionis Pharmaceuticals, Inc.

Industry

Registry information

Official study title

A Blinded, Placebo-Controlled, Dose-Escalation, Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ISIS 757456 Administered Subcutaneously to Healthy Volunteers

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 5, 2017
Registry last updated
Aug 21, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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